JP6096779B2 - Analysis device having optical filter and analysis method - Google Patents

Description

  The present invention relates to biological assays, pathogens, devices for molecular analysis, and systems and methods for such analysis. The present invention can be used for biological assays such as sandwich analysis and competitive assays, such as immunoassays, among others, fluorescent immunoassays (FIAs).

  The optical analysis system can be used to quantitatively, semi-quantitatively or qualitatively determine the presence, concentration or amount of target material or analyte in a test sample.

  However, while such a system can be used successfully, it suffers from a number of disadvantages. For example, to perform analyzes that are not appropriate for some decisions or not available for some tests, they require the use of relatively expensive equipment. For example, in some cases a qualitative determination of the presence of an analyte is sufficient, while in other cases a quantitative determination may be necessary. Furthermore, such a test may have limited performance that leads to retesting. In addition, there is a general desire to reduce the cost of equipment used for analysis and to reduce the time required to perform tests. In other cases, it may not be desirable to perform such an analysis under laboratory conditions, but instead it may be necessary to perform tests in the field with minimal equipment. Absent.

  According to one embodiment, the present invention provides an analytical device for allowing a test to be performed on a specimen. The analytical device has a sample injection zone for receiving an amount of analyte, a waste zone, and a path that allows movement of the analyte from the sample injection zone to the waste zone. In one embodiment, it includes an amount of labeling material that emits or modifies light and binds to the analyte, at least when activated. The path has a capture zone located between the sample injection zone and the waste zone, the capture zone having a quantity of capture material. The capture material is fixed in the path and binds to the analyte moving along the path. Thus, the specimen is fixed to the route. The analytical device has a first optical filter on the first side that allows transmission of light emitted or modified by the labeling material and blocks light in at least one other wavelength range, the analytical device Light that is illuminated from the second side and emitted or altered by the labeling material placed in the path can be detected from the opposite side (first side).

  Analytical devices can be used to perform other forms of testing, such as lateral flow testing, or through-flow device testing and microfluidic testing, and indeed for competitive assays and sandwich analysis Can be used for any test used.

  This form of analytical device can be used in a number of ways. For example, it can be used with a reader and illumination to detect trace analytes or perform quantitative tests on the analytes. However, in other environments, the analytical device can be an independent or stand-alone device that is simply used without a reader to perform low sensitivity or qualitative tests to determine the presence or absence of an analyte. Can be.

  According to another embodiment, the present invention provides a combination comprising an analytical device and a reader for detecting the output from the illuminated analytical device. The reader includes a light source for applying light to one surface of the analysis device, a power source for the light source (or a terminal for power supply connection), and a photodetector for detecting light emitted by the analysis device. Can have.

According to yet another embodiment, the present invention provides a method for performing an analysis, eg, a lateral flow test. The method includes adding an amount of analyte to the analytical device, moving the analyte along the analytical device so that it is fixed in the path by the capture material, and then detecting the extent to which the labeling material modifies the light. Thereby illuminating the analytical material to detect the presence or absence of the analyte or the amount of the analyte. Thus, the method comprises the step of moving an analyte along a path to a capture zone and beyond the capture zone when an amount of analyte is added to the sample injection zone, where the path is routed to the analyte. An amount of labeling material that includes an amount of capture material to be fixed and emits or alters light at least when activated so that the analyte and the labeling material are immobilized in the pathway in the capture zone Contacting the sample with an amount of labeling material that binds to the sample,
Adding an amount of wash solution to the sample injection zone to flow excess analyte and labeling material along the path to the waste zone;
Illuminating one side of the analytical device and detecting light emitted or altered by the labeling material from the opposite side of the analytical device, wherein the opposite side of the analytical device is emitted by the labeled material Or having an optical filter that allows the transmission of light to be modified and blocks light of at least another wavelength, and detection of light indicates the presence or amount of the analyte.

  Typically, the analytical device has a labeling zone in which a quantity of labeling material is placed, which is preferably located in the path between the sample injection zone and the capture zone. Thus, as soon as the sample is injected, the sample contacts the labeling material, and the sample and the labeling material move together along the path to the capture zone. However, in a broad aspect of the invention, when an analytical device is supplied, it is not necessary that the marker material be placed in the path of the analytical device. Labeling material can be supplied separately and added to the analytical device along with the analyte. Alternatively, the labeling material may be mixed with the specimen in advance, ie before adding the specimen to the analytical device.

1 is a schematic perspective view of an analysis device and a reader according to the present invention. FIG. 2 is a more detailed view of the analysis device of FIG. FIG. 3 is an exploded view of the analytical device shown in FIG. 2 showing its various components. 2 is a graphical representation of the emission and absorption spectra of one form of labeling material that can be used in an analytical device. FIG. 6 is a view of the analytical device with the top surface removed to show the interior in detail. It is the schematic of an analysis device and a reader. FIG. 2 is a diagram of an analytical device under test according to the present invention. The analytical device at one point during the test is shown. Figure 2 shows the analytical device at another point during the test.

  An example of the present invention will be described below with reference to the drawings.

  FIG. 1 shows an analytical device or test strip 1 and a reader 2 that make it possible to perform quantitative or qualitative tests on a specimen. In one embodiment of the invention, an amount of analyte is added to one side of the analytical device and flows to the opposite side along the path of the analytical device. Then, the analysis device is inserted into the reader 2 and an output indicating the amount of the sample is obtained on the display 4 of the reader 2.

  2 and 3 show the shape of the analytical device in more detail. As shown in FIG. 3, the analysis device has a substantially transparent bottom cover 6 and a substantially transparent top cover 8, and the top cover 8 covers and is coupled to the bottom cover 6. The top cover 8 has an area 9 to which a physical label is attached for information. The top cover 8 and the bottom cover 6 are made of a plastic material, and the entire surface is transparent. But this is not essential. It is only necessary that the top cover 8 and the bottom cover 6 are transparent in the region of the path 10 along which the specimen moves. The top cover 8 and the bottom cover 6 include a plurality of paths 10. In the present embodiment, there are two paths 10, that is, a path for detecting an analyte and a control path. However, other numbers of paths may be used, for example, multiple different analytes may be detected using the same analytical device. The passage 10 is formed from a porous material such as nitrocellulose. A path 10 extends from a sample injection zone (or application zone) 14 (see FIG. 5), which is in one region of the analytical device, into which the analyte is injected during the test, to a region at the other end where the analyte moves during the test . In this configuration of the analytical device, the thickness of the transparent top cover 8 is reduced along the thin region 11 extending along a portion of the path 10 so that the path can be more easily viewed through the transparent top cover 8. . A cleaning liquid collection container 12 is provided in the other end region of the analysis device, and the cleaning liquid is added to the path 10 so that the specimen flows along the path 10 to the cleaning liquid collection container 12.

  A quantity of label, including a label precursor, is provided in a label / primary receptor zone 16 located between the sample injection zone 14 and the waste or wash collection container 12 in one or both of the pathways 10. As the specimen moves along the path 10, the label is absorbed by the specimen and moves along the path 10 together with the specimen. A unique bond can be formed between the label and the analyte. For example, antibody pairs, bonds between antigen pairs, DNA bonds, or other bonds can be formed. In one example, the analyte is avidin, streptavidin, or neutravidin, but the labeling material is biotinylated. Thus, the label forms a biotin-avidin bond with the analyte. Thus, the presence of the analyte can be detected by subsequently observing the presence of the label. Below, it demonstrates in detail about a label | marker.

  Downstream of the label and primary receptor zone 16 along the path 10 is a capture zone 18 (see FIG. 5), where a certain amount of capture material is located. The capture material is fixed in the path 10 and binds to any analyte that passes along the path 10. Therefore, the specimen is held at the position of the path 10 corresponding to the capture material. As described above, in the case of detection devices used to detect avidin, streptavidin, or neutravidin, the capture material is biotin such that the analyte is immobilized in pathway 10 by biotin-avidin binding. Can be

  During the test, an amount of analyte is injected at an injection port 20 (see FIG. 2) located above the sample injection zone 14 in one of the paths 10. The sample can be injected by a pipette, dropper, or other suitable instrument as shown in FIG. 7 for injecting a predetermined amount of sample. An amount of control analyte is injected into an injection port 21 located above the sample injection zone 14 of the other path 10. The control analyte exhibits a known strong binding between the labeling material and the capture material. Then, so that the operator can confirm that the specimen has been injected during the test, there is a control sign indicating a predetermined strong signal when the analysis device is irradiated with light (the control sign is another path 10). The label may be the same as or different from that used in the above).

  In the case of quantitative analysis, the signal generated from the control sign can be used for reference. The signal from the analyte / label signal is compared to that signal. For example, control analyte / control label binding and control analyte / control capture material binding can be based on biotin-avidin binding or similar binding as described above. Initially, the specimen wets the path 10 located below the injection ports 20 and 21 indicated by the hatched area in FIG. The analyte moves along the path 10 by capillary action carrying the label from the label / primary receptor zone 16 of FIG. In the capture zone 18, the analyte and the label stick to the path 10 as indicated by the hatched area in FIG. There is a process control zone 26 downstream of the capture zone 18 on each path 10 or on each path 10, which is located below the process control window 28 on the top surface of the analytical device. After injection, the specimen moves along the path 10 by capillary action, causing a color change and hydrating the path 10. The path 10 can be viewed through the process control window 28 to observe the color change and to verify that the analyte and label have moved to and beyond the capture zone 18.

A cleaning solution can be added such that the sample, control sample, and label flow along the path 10 to the cleaning solution collection container 12. The cleaning solution can be added in various ways. For example, wash fluid can be added to the sample injection port or alternative port by a pipette, dropper, or other instrument that injects a volume of wash fluid into the injection ports 20 and 21. In addition, the cleaning liquid injection container 24 may be disposed at the end of the analysis device opposite to the cleaning liquid collection container 12 or at the side of the analysis device. The cleaning fluid injection container 24 can be in the form of a bladder, blister pack, or sachet that is stabbed to allow cleaning fluid to flow along the path 10. In other forms where a reader is used, as described below, the reader is designed to receive an analytical device and has a top or protrusion. When the analytical device is inserted into the reader, the top or protrusion applies pressure to the cleaning fluid injection container 24 and tears it. Therefore, the cleaning liquid automatically flows into the reader when the analysis device is inserted.
Once the wash solution has been added, there is essentially no material in the path 10 other than the analyte immobilized on the capture zone 18 and the label immobilized on the analyte.

  In many forms of capture and label placement, as soon as the analytical device is washed, it is illuminated and ready to be read. However, in some cases, further processing steps may be required to activate the label, which is sometimes referred to herein as a label precursor. For example, there are several types of fluorescent labels used, as described below, especially fluorescein diacetate (FDA), which hydrolyzes the precursor and / or heats it to release the label. It is necessary to. This operation is executed at an appropriate timing. For example, if an acid or base hydrolysis step is required, an appropriate acid or base can be added before and after injection of the analyte, eg, with a wash step. In this case, the cleaning solution in the cleaning solution container may have a pH that will cause hydrolysis so that the activation step occurs automatically with the cleaning step.

  The analytical device is now ready to be lit to detect the presence of the analyte. This can be achieved by the reader shown in FIGS. The reader has a housing with a hole or slot 35 in it for receiving the analytical device 1. A light source 32, such as an LED or an incandescent bulb, is disposed on one side of the slot for receiving the analytical device, and a photo sensor, such as a PIN diode or avalanche photodiode, is disposed on the opposite side of the slot from the light source. Light passes through the analytical device. The light source can be powered by a standard battery 36 or other power source such as a transformer. The reader has a conventional signal processor 38 for controlling the light source driving circuit 40, the detection signal amplification circuit 42, and the display 4 display circuit.

  Desirably, the analytical device has a contour with a truncated corner to ensure that it is not inserted upside down or back and forth. As will be appreciated, inserting the analysis device upside down causes the excitation wavelength to be removed by the long wavelength filter on the top surface of the analysis device. Such a cornered profile has a cut corner 29 that works with the corresponding corner of the leader. Also, there is an arcuate notch at one end of the analytical device to ensure that the end of the analytical device is inserted. Many other cornered contours may be used.

  In some cases, the analytical device is illuminated as soon as the path 10 is cleaned. However, in other cases it may be necessary to wait for some time before shining, in which case the reader will be able to illuminate and read the analytical device at the appropriate time. A timer can be provided. For example, in the case of base hydrolyzed FDA, it is advantageous to wait between 100 seconds and 500 seconds after the hydrolysis and before exposure to light.

  Here, although the term “light” is used, it is understood that this is because the analytical device is intended for visual reading. In principle, any electromagnetic radiation can be used to read the analytical device. And although visible light is desirable, the light need not necessarily be visible light. The light may have an infrared or ultraviolet spectral component, and may have a spectrum where the radiation is primarily in a wavelength range outside the visible light wavelength range. However, as explained below, it is desirable that the light is in the visible light range.

The labeling material placed on the analytical device is one that emits light or changes light at least when activated. Thus, the light emitted from the analytical device due to the presence of the analyte is different from the light from the light source.
One side of the analytical device that receives the light only after it has passed through the labeling material, i.e. the top cover 8 in this embodiment, is formed from a material that provides the first optical filter, which is filtered by the labeling material. Permits transmission of emitted or modified light and blocks light in at least another wavelength range. This has the advantage of enhancing the effectiveness of the marking material by removing at least some of the background light that is not affected by the marking material.

Desirably the other side of the analytical device, i.e. the side that is illuminated by the light source during the reading phase, is also formed from a second optical filter, which is different from the light transmission characteristics of the first optical filter. Has characteristics.
In a preferred form of the analytical device, the second optical filter allows transmission of light in a wavelength range shorter than the wavelength range of the first optical filter. For example, the first optical filter may be a green filter while the second optical filter may be a blue filter. In particular, the optical filters cooperate to block light in substantially the entire visible light range. In other words, in the preferred form of the analytical device, the long wavelength blocking of the second optical filter is substantially the same as the blocking of the short wavelength region of the first optical filter, and the combination of the two optical filters is substantially To block all visible light.

  The optical filters provided at the top and bottom of the analytical device can be formed of any suitable material, such as glass, plastic material, thin film material. Or they can be holographic filters or interference filters. In interference filters, dielectric films are deposited in multiple layers to transmit only the desired wavelength and reflect light of other wavelengths. However, given that the optical filter is provided in a consumable analytical device, the material should be relatively inexpensive and a plastic filter is desirable.

  If the labeling material is a fluorescent or phosphorescent material that exhibits a Stokes shift between the absorption and emission spectra, the filters formed on both sides of the analytical device will block substantially all light. Can pass the fluorescence or phosphorescence produced by the label to be detected. For example, FIG. 4 shows an absorption spectrum (graph A) having a maximum at 492 nm and an emission spectrum (graph B) having a maximum at 517 nm of fluorescein that can be used as a labeling material. As shown in the figure, the use of the second optical filter that blocks the long wavelength in the 500 nm region and the second optical filter that blocks the short wavelength in the 500 nm region substantially reduces the fluorescence from the fluorescein on a dark background. Allowing to be observed against.

  As mentioned above, the use of labels that can affect the wavelength of light, such as fluorescent or phosphorescent materials, with optical filters on both sides of the analytical device (rather than that the filter is associated with a reader) , Allowing at least a large number of tests (eg many qualitative tests or tests where high concentrations of analytes are present) to be dispensed with, and simply pointing the analytical device to a white light source such as the sun This has the significant advantage that the presence or absence of a band on the path 10 caused by the fluorescent label can be observed.

  According to the broadest aspect of the present invention, multiple labeling materials can be used in the analytical device. These include simple colored dyes or pigments that affect the absorption spectrum of the analyte. However, they are preferably fluorescent materials, phosphorescent materials or chemiluminescent materials. Examples of materials used as labels are disclosed in US Pat. No. 7,796,266, the disclosure of which is hereby incorporated by reference. Furthermore, the term “label” as used herein can optionally include a precursor of the label, but before the material acts as a photolabel, there are some additional steps such as acid or base Hydrolysis, heating, or both may be necessary.

According to one desirable embodiment, the labeling material comprises a lipid walled capsule, which optionally has a polymer shell and comprises a signal precursor. Such a form of labeling material is disclosed in the international patent application WO 02 / 12888A2, the disclosure of which is hereby incorporated by reference.
For example, the capsule is formed from the lipid DSPE-PEG2000 amine and sodium dodecyl sulfate (SDS) and can contain fluorescein diacetate (FDA) as a signal precursor. These capsules can be activated by being placed in an activation solution having a pH of about 10.1 and then heated. The pH of the activation solution is selected such that the FDA in this type of capsule is below the value of pH that undergoes rapid hydrolysis to fluorescein without additional heating.

  Capsules such as those disclosed in International Patent Application No. WO 02 / 12888A2 release large amounts of fluorescent or phosphorescent material when activated. That is, the capsule contains billions of fluorescent or phosphorescent material molecules, so that the intensity of the emitted light is not encapsulated in other analytical methods that use fluorescent or phosphorescent materials. Analyzes using these capsules can be extremely accurate because they are several orders of magnitude greater than the intensity. Individual capsules can potentially bind to a single molecule of target material in the analyte solution. Then, when released from the capsule to which the fluorescent or phosphorescent molecule is bound, billions of signal generating molecules are released for each molecule of the target material. Thus, even with small amounts of target material, the analysis is very accurate.

  For example, for a capsule containing FDA, when activated, this very high degree of fluorescence is generated by the capsule containing FDA and is relatively inexpensive and poorly placed on a consumable part such as an analytical device. It is speculated that the FDA-containing capsule can be used with an analytical device according to the invention that uses an optical filter. According to the above-mentioned US Pat. No. 7,796,266, for example, a large Stokes shift from 100 nm to 350 nm eliminates the need for expensive high precision filters used in light detection to remove background interference. Minimize. However, the fluorescein used in the present invention has a Stokes shift of only about 25 nm to 28 nm.

  In practice, the use of fluorescent or phosphorescent labels, particularly labels formed with capsules containing the aforementioned FDA, can show the absorption spectrum of the fluorescein when the analytical device is exposed to white light or ambient light. Can have the effect. Thus, according to yet another aspect, the method according to the present invention analyzes from one side with white light or ambient light to detect absorption bands in the path 10 caused by absorption of light by the fluorescent labeling material. Illuminating the device and observing the analytical device from the other side. This method does not require the use of a reader with a special light source and detector. In order to reduce the intensity of light that passes through the analytical device unaffected by absorption by the fluorescent or phosphorescent material and increase the percentage of light absorbed by the fluorescent or phosphorescent material, Although it is advantageous to have an optional second optical filter on the lighted side, it is not essential to have that second optical filter.

  The ability of the encapsulated signal generating molecule to generate a detectable signal for extremely low concentrations of the target material gives the analytical device of the present invention great utility. When such encapsulated signal generating molecules are integrated into or used in an analytical device, even at the point of care, even if the user does not have access to the reader You can make a decision. Thus, the analytical device can be used at remote locations, in field applications, or in any environment where access to the reader is not available.

Claims (35)

A single analytical device that enables tests to be performed on specimens,
The analytical device has a sample injection zone for injecting a quantity of analyte, a waste zone, and a path that allows movement of the analyte from the sample injection zone to the waste zone;
The analytical device has a first cover on a first side of the path and a second cover on a second side opposite the first side;
The first cover provides a first optical filter that allows transmission of light emitted or modified by the marker material and blocks light in at least one other wavelength range;
The second cover forms a second optical filter, and the second optical filter has characteristics different from the light transmission characteristics of the first optical filter;
The analytical device includes an amount of the labeling material that emits or alters light at least when activated, the labeling material binds to an analyte;
The pathway includes a capture zone disposed between the sample injection zone and the waste zone, the capture zone having an amount of capture material secured to the pathway, and the analyte secured to the pathway So that the capture material binds to the analyte moving along the path,
The analysis device is illuminated from the second side by a light source separated from the analysis device, and light emitted or modified by the labeling material disposed in the path is from the first side. Configured to be detected,
An analysis device characterized by that.   The analysis device according to claim 1, wherein the first cover is formed of a material that provides the first optical filter.   The analysis device according to claim 1 or 2, wherein the first cover and the second cover are made of a plastic material.   The analysis device according to claim 1, wherein the combination of the first optical filter and the second optical filter blocks substantially all visible light.   The analysis device according to claim 1 or 2, wherein the second optical filter transmits light having a shorter wavelength than light transmitted by the first optical filter.   The labeling material is a fluorescent material or phosphorescent material or a precursor of the fluorescent material or phosphorescent material, and the first optical filter allows only light after being modified by the labeling material The analysis device according to claim 5.   The analytical device of claim 1, wherein the first optical filter allows transmission of light of different wavelengths corresponding to light emitted or modified by different labeling materials.   The analysis device according to claim 1, comprising a plurality of different optical filters arranged at different positions on the path.   The analysis device according to claim 1, wherein the analysis device has a plurality of paths for movement of different specimens.   10. A plurality of different optical filters that allow transmission of light emitted or altered by the marker material, each optical filter being associated with a different path. Analytical device.   The analytical device of claim 1, wherein the labeling material is held in a labeling zone disposed between the sample injection zone and the capture zone.   A process control zone located between the capture zone and the waste zone, wherein a visual inspection of the path is possible in the process control zone to determine the extent of movement of the analyte. 2. The analysis device according to 1.   The analytical device of claim 1, further comprising a carrier container to allow the specimen to travel along a path to the waste zone.   The analysis device according to claim 13, wherein the container can be torn manually.   14. The analytical device of claim 13, wherein the container is in the shape of a bladder, blister pack, or sachet.   The analytical device of claim 1, comprising an additional path that receives a control sample and allows the control sample to move to the capture zone.   A plurality of paths extending generally parallel to each other from the sample injection zone to the waste zone, the paths including different capture materials so that the test can be performed on a plurality of different analytes. 2. The analysis device according to 1.   The analytical device according to claim 1, wherein the analytical device is prepared so that a lateral flow or microfluidic test can be performed on the specimen. An arrangement for performing an analysis comprising the analysis device according to claim 1 and a reader for detecting an output from the analysis device,
A body having a slot in which the reader can receive the analysis device; a light source that irradiates light to the analysis device from the second side when the reader receives the analysis device; and a power source for the light source. A terminal, a photodetector disposed on the body for detecting emitted light from a first side of the analytical device, and a detector for detecting the power of the light detected by the photodetector Arrangement characterized by having.   20. The reader comprises a display for displaying data defining light power detected by the photodetector or data relating to light absorption by a material in the analytical device. Arrangement described.   The arrangement of claim 19, wherein the reader comprises a protrusion that applies pressure to a portion of the analytical device when the analytical device is inserted into the slot.   It comprises a plurality of photodetectors for detecting light from a light source that passes through an analysis device inserted into the slot, and each of the photodetectors is arranged at a different position on the body of the reader. The arrangement of claim 19. A specimen test method for testing a specimen by a single analytical device, wherein the analytical device is configured to inject a specimen injection zone for injecting a specimen, a waste zone, and movement of the specimen from the sample injection zone to the waste zone. Having a path to enable, having a first cover on a first side of the path and a second cover on a second side opposite the first side, the path being the sample In an analyte test method comprising a capture zone located between an injection zone and the waste zone, the capture zone having a quantity of capture material, the capture material being fixed in the pathway, and binding to the analyte ,
Moving an amount of the analyte along the path to the capture zone and beyond the capture zone when an amount of the analyte is added to the sample injection zone, wherein the path is the analyte in the capture zone Including an amount of capture material that secures to the pathway;
An amount of labeling material that emits or changes light at least when activated before or after reaching the capture zone, wherein the analyte and the labeling material in the capture zone Contacting the analyte with an amount of the labeling material that binds to the analyte so that is immobilized in the pathway;
Adding an amount of wash solution to the sample injection zone to flow excess analyte and labeling material along the path to the waste zone;
Illuminating the analytical device from the second side and detecting light emitted or altered by the labeling material from the first side of the analytical device, the first of the analytical device comprising: One cover provides an optical filter that allows transmission of light emitted or altered by the labeling material and blocks light of at least one other wavelength, the detection of the light being indicative of the presence or amount of the analyte. The second cover of the analytical device forms a second optical filter having characteristics different from the light transmission characteristics of the first optical filter;
A specimen test method characterized by the above.   24. The specimen test method according to claim 23, wherein the first cover is made of a material that provides the first optical filter.   25. The specimen test method according to claim 23 or 24, wherein the first cover and the second cover are made of a plastic material.   24. The specimen test method according to claim 23, wherein the combination of the first optical filter and the second optical filter blocks substantially all visible light.   24. The specimen test method according to claim 23, wherein the analysis device includes the labeling material before starting a test.   28. The specimen test method according to claim 27, wherein the labeling material is provided when the analysis device is manufactured.   The path includes the labeling material in a zone between the sample injection zone and the capture zone, and is associated with the analyte when the labeling material is moving along the path to the capture zone. The specimen test method according to claim 23.   24. The specimen test method according to claim 23, further comprising adding an amount of the labeling material to the analysis device.   24. The specimen test method according to claim 23, wherein the test is a lateral flow or microfluidic test.   A step of inserting the analysis device into a reader for detecting an output from the analysis device, wherein the reader has a body having a slot capable of receiving the analysis device, and when the reader receives the analysis device, A light source that illuminates the analysis device from the side of the light source, a light detector disposed on the body opposite the slot to detect light emitted by the analysis device, and light detected by the light detector 24. The specimen test method according to claim 23, wherein the specimen test method has an arrangement for detecting the power of the specimen.   24. The specimen test method according to claim 23, further comprising the step of irradiating the analysis device with white light on one side and observing the opposite side to determine the presence or amount of the specimen from the labeling material.   The specimen test method according to claim 33, wherein the labeling material includes a fluorescent material or a phosphorescent material.   34. The analyte test method of claim 33, comprising determining a position on the path where light is absorbed by the marker material.

Images